NL-OMON22556
Recruiting
Not Applicable
Cerebellar stimulation to treat refractory epilepsy in children
ConditionsRefractory epilepsy
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Refractory epilepsy
- Sponsor
- Erasmus MC
- Enrollment
- 9
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Refractory epilepsy for at least one year, with a seizure frequency of at least four per month.
- •Failure of at least three adequately tried AED regimens, as determined by the principal investigator, including ketogenic diet if appropriate.
- •Age 4 – 18 years at time of inclusion. The first 3 patients are at least 7 years old.
- •Definite diagnosis of epilepsy syndrome as reported by treating clinician according to international standards and confirmed by recruitment team.
- •Written informed consent of parents/caretakers.
Exclusion Criteria
- •Other progressive neurologic or medical diseases.
- •Evident co\-existing non\-epileptic seizures.
- •Candidate for resective epilepsy surgery.
- •Inability to complete neuropsychological tests or complete seizure diaries by caretakers.
- •Vagal nerve stimulators in situ.
- •Surgical contraindications such as coagulation disorders.
- •Contraindications for MRI.
- •Anatomical abnormalities of skull and posterior fossa, precluding safe lead placement and fixation.
- •Immune deficiency.
- •Insufficient space or subcutaneous fat to safely implant stimulator.
Outcomes
Primary Outcomes
Not specified
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